Deferasirox, Oral

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KEY POINTS

• This medicine is taken by mouth to treat excess iron in the body from blood transfusions or thalassemia. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious or life-threatening side effects, such as kidney or liver problems, bleeding in the stomach or intestines, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: chelating agent; antidote

Generic and brand names: deferasirox, oral; Exjade; Jadenu

What is this medicine used for?

This medicine is taken by mouth to treat excess iron in the body from blood transfusions or thalassemia.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A bone marrow disorder such as myelodysplastic syndrome
• Bleeding problems or a blood disorder such as anemia or sickle cell disease
• Cancer
• Eye problems such as cataracts and glaucoma
• Hearing problems
• Kidney or liver disease
• Stomach or intestinal problems such as ulcerative colitis, Crohn's disease, heartburn, ulcers or bleeding

Females of childbearing age: Tell your healthcare provider if you are pregnant or if you plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take the medicine exactly as prescribed by your healthcare provider. Do not take more or less or take it longer time than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 2.

Take this medicine 2 hours before or 3 hours after taking an antacid that contains aluminum.

If you have the dissolving tablets, dissolve them completely in water, orange juice, or apple juice. Drink the mixture immediately. After drinking the mixture, add a small amount of liquid to the glass, swirl it around, and drink that too. Do not chew the tablets. Take the medicine at the same time each day on an empty stomach at least 30 minutes before eating any food.

If you have the regular tablets, swallow them with water. Take the medicine at the same time each day on an empty stomach or with a light meal, such as a muffin or small turkey sandwich. If you have trouble swallowing the tablets, you may crush them and mix with yogurt or applesauce. Eat the mixture right away.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, diarrhea, yellowing of eyes or skin, severe stomach pain.

What should I watch out for?

This medicine may cause serious or life-threatening side effects such as kidney, pancreas, or liver problems, or bleeding in the stomach or intestines. You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments. Talk with your healthcare provider about this.

You will need to have regular hearing tests and eye exams while taking this medicine. If you notice changes in your vision or hearing, contact your healthcare provider.

If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are receiving this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Rash or peeling skin, severe stomach pain, fever, headache, trouble hearing or seeing, confusion, coughing blood, vomiting blood, black or tarry bowel movements, severe leg cramps, trouble urinating or decreased urination, yellowing of the skin or eyes, unusual bruising or bleeding, unusual tiredness or weakness, sore throat.

Other: Dizziness, diarrhea, nausea, vomiting, stomach pain, muscle aches and pains, mild tiredness, stuffy nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antacids that contain aluminum or magnesium, such as Gaviscon, Maalox, and Mylanta (Take antacids 2 to 3 hours before or 2 to 3 hours after you take this medicine.)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), midazolam (Versed), and triazolam (Halcion)
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), and rifampin (Rifadin)
• Antidepressants such as clomipramine (Anafranil), duloxetine (Cymbalta), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), and nefazodone
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), clozapine (Clozaril, FazaClo), haloperidol (Haldol), lurasidone (Latuda), olanzapine (Zyprexa), pimozide (Orap), quetiapine (Seroquel), and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Budesonide (Entocort, Rhinocort, Uceris)
• Cancer medicines such as dasatinib (Sprycel), doxorubicin (Doxil), enzalutamide (Xtandi), everolimus (Afinitor, Zortress), imatinib (Gleevec), paclitaxel (Abraxane, Taxol), tamoxifen, vinblastine, and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), lovastatin (Altoprev), and simvastatin (Zocor)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Darifenacin (Enablex)
• Deferoxamine (Desferal)
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), felodipine, mexiletine, nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), propafenone (Rythmol), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat breathing or lung problems such as fluticasone (Flonase, Flovent, Veramyst), pirfenidone (Esbriet), theophylline, and zileuton (Zyflo)
• Medicines to treat or prevent blood clots such as dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticagrelor (Brilinta), and warfarin (Coumadin)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), frovatriptan (Frova), isometheptene/dichloralphenazone/acetaminophen, rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Muscle relaxants such as cyclobenzaprine (Amrix) and tizanidine (Zanaflex)
• Nausea medicines such as alosetron (Lotronex), aprepitant (Emend) and ondansetron (Zofran)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Osteoporosis medicines such as alendronate (Fosamax), ibandronate (Boniva), and risedronate (Actonel, Atelvia)
• Ramelteon (Rozerem)
• Rasagiline (Azilect)
• Ropinirole (Requip)
• Tolvaptan (Samsca)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, moisture, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.